First prescriptions delivered to individuals with PWS
Soleno Therapeutics, Inc., a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced the U.S. commercial availability of VYKAT XR (diazoxide choline) extended-release tablets, the company’s treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025.
Prescriptions of VYKAT XR have now been delivered to the first individuals living with PWS who have been prescribed the medication.
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“We are extremely pleased to begin delivering VYKAT XR, the only FDA-approved treatment for hyperphagia, to individuals living with PWS. Hyperphagia, the hallmark condition of PWS, is the leading cause of mortality in the PWS population and creates a significant burden for caregivers,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Since FDA approval, we have seen strong interest in VYKAT XR. Our team is fully prepared to meet demand and is well-positioned to execute a successful commercial launch of this first-to-market treatment. These first shipments mark an important step in our efforts to deliver this new treatment to the PWS community and are an exciting milestone reflecting our dedication to ensuring timely access to treatment.”
Soleno has established a comprehensive support program, Soleno ONE™, to assist patients, caregivers and healthcare providers with access to VYKAT XR.
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Source – GlobeNewswire
